Adaptor for an introducer valve in a human or animal body

ABSTRACT

An adaptor ( 1 ) for the valve ( 15 ) of an introducer ( 16 ) in a human or animal body, characterized in that it comprises an outer surface ( 2 ) adapted to cooperate with the valve ( 15 ); its interior volume ( 3 ) comprises at least one duct ( 4 ) for allowing surgical or medical instruments having an elongate body to pass through; and the duct ( 4 ) comprises waterproofing means. The duct ( 4 ) of the adaptor ( 1 ) comprises waterproofing means at its proximal end ( 6 ) and/or at its distal end ( 5 ).

The invention relates to a valve introducer fitted with an adaptor forintroduction into a human or animal body.

It will be of particular use in vascular surgery.

The instruments introduced into a human or animal body require thepresence of shutter components to ensure that the introducer isleakproof.

This is particular true during endovascular surgery with theintroduction of surgical instruments in an introducer since there mustnot be any backflow of blood through the introducer.

Valves for surgical instruments deformable by twisting already exist toincrease the leakproof qualities of the instrument.

This solution is not fully satisfactory because when introducing severalsurgical instruments such as catheters and guides, there remains a gapbetween the instruments despite the valve, causing a leakage of blood.

Document WO00/32263 has already described an introducer device for usein the human body comprising a main elongated body fitted, at theproximal end, with several openings for surgical instruments. The devicehas leakage problems because the main elongated body is introduceddirectly into the human body and the instruments pass through it.

Moreover, the system is not very easy to use because, once the devicehas been introduced, there cannot be any change in diameter or in thenumber of openings in the proximal extremity without withdrawing thedevice, thereby leading to leakage of fluid from the human body.

There is therefore a need for a device that allows for the simultaneoususe of several surgical instruments or instruments of very differentsizes via an introducer in the human or animal body that produces a goodseal and is easy to use.

To this end, the invention proposes a valve introducer for the human oranimal body, characterised in that it comprises an adaptor whose outersurface is adapted to cooperate with the valve, an interior volume withat least one duct for allowing surgical or medical instruments having anelongated body to pass through and leakproof means.

According to one embodiment, the ducts of the adaptor comprise leakproofmeans at their proximal end and/or at their distal end.

Advantageously, the adaptor consists of an elongated, cylindrical bodyable to cooperate with a valve deformable by twisting.

The leakproof means in the ducts and the elongated body ensure that theadaptor and the adaptor-introducer are well-sealed.

Advantageously, the leakproof means at the distal extremity are alsodesigned to avoid excessive movement of catheters by maintaining them inposition along a certain axis.

The leakproof means at the distal end also plays a centring role.

Advantageously, the adaptor is characterised by an outer surface able tocooperate with the introducer and the means of attachment to theintroducer.

Advantageously, the adaptor is characterised by a conical distalextremity designed to improve the insertion of the adaptor in theintroducer by cooperating with a flat centring valve in the introducerand/or by causing the leakproof valve in the introducer to open,especially if the introducer is fitted with a leakproof valve deformableby twisting.

According to one embodiment, the adaptor ducts consist of a section thatis more or less longitudinal compared to the body of the adaptor. Theyalso have a divergent proximal section. This makes it easier tomanipulate the surgical instruments introduced in the adaptor.

Advantageously, the centres of the proximal openings in the ducts lie ina predetermined circle.

According to one embodiment, a channel is located in the centre of thecircle predetermined by the proximal openings of the ducts and,advantageously, this channel has the same leakproof means as the ducts.

Advantageously, the said channel is rectilinear to facilitate thehandling of surgical instruments and especially the passage of a guidewire.

Other aims and advantages will become apparent during the followingdescription of a preferred embodiment of the invention. However, thisembodiment is not limitative.

It is appropriate to remember that the invention relates to a valveintroducer for the human or animal body, characterised in that the valveis deformable by twisting and able to cooperate with an adaptor via itsouter surface; the inner volume of the said adaptor comprises at leastone duct allowing the passage of surgical or medical instruments with anelongated body; and the duct comprises leakproof means.

According to the preferred variations of the invention, the introduceris such that:

-   -   the duct in the adaptor comprises leakproof means at its        proximal end,    -   the leakproof means at the proximal end of the adaptor duct        include a haemostatic valve,    -   the duct in the adaptor comprises leakproof means at its distal        end,    -   the leakproof means at the distal end of the adaptor duct        include a haemostatic valve,    -   the haemostatic valve is held in place between a support and a        washer,    -   the centres of the proximal openings of the adaptor ducts are        located in a predetermined circle,    -   a channel is located in the centre of the circle predetermined        by the proximal openings of the adaptor ducts and the said        channel is rectilinear,    -   the adaptor ducts consist of a section that is roughly        longitudinal compared to the elongated body of the adaptor and a        divergent proximal section,    -   the adaptor ducts have different diameters,    -   the adaptor includes a conical distal extremity,    -   the adaptor comprises means of attachment to the introducer,    -   the adaptor includes a cylindrical elongated body,

According to the preferred variations of the invention, the introduceris such that:

-   -   it is fitted with a valve deformable by twisting which        cooperates with an adaptor via its outer surface as previously        described,    -   it has a flat centring valve able to cooperate with the distal        end of the adaptor to facilitate its insertion by centring it.

The enclosed drawings are given as examples and do limit the scope ofthe invention. They represent only one embodiment of the invention andwill make it easily understandable.

FIG. 1: longitudinal section of the adaptor.

FIG. 2: cross-section from the distal end of the adaptor according toFIG. 1.

FIG. 3: cross-section from the proximal end of the adaptor according toFIG. 1.

FIG. 4: view of the elongated body of the adaptor according to thecross-section line AA of FIG. 1.

FIG. 5: longitudinal section of the adaptor according to the embodimentcomprising a central channel.

FIG. 6: cross-section from the distal end of the adaptor according toFIG. 5.

FIG. 7: cross-section from the proximal end of the adaptor according toFIG. 5.

FIG. 8: view of the elongated body of the adaptor according to thecross-section line BB of FIG. 5.

FIG. 9: longitudinal section of the adaptor and introducer.

FIG. 10: longitudinal section of the adaptor mounted on the introducer.

FIG. 11: cross-section from the distal end of the adaptor according toFIG. 10.

Adaptor (1) for valve (15) of the introducer (16) in the human or animalbody comprises an outer surface (2) able to cooperate with valve (15).

Adaptor (1) comprises an elongated body (17) advantageously cylindricalin shape able to cooperate with valve (15) of introducer (16).

Advantageously, a sort of skirt (18) partially covers the elongated body(17) of adaptor (1).

According to one embodiment, valve (15) of introducer (16) is a valvedeformable by twisting.

Valve (15) is comprised of a soft portion that is more or lesscylindrical in shape consisting of a hollow section of flexibleleakproof material such as silicone.

Both extremities (19) and (20) of valve (15) are joined to other partsused in the twisting of valve (15).

If there is no stress on the flexible portion, its centre is completelyopen allowing for the passage of surgical or medical instruments throughvalve (15).

Using cursor (21), the operator rotates extremity (20) by means of acable. Twisting of the flexible section then tends to create an area ofnarrowing approximately in the middle of the flexible portionlengthways.

When an object is to be introduced through valve (15), the operatoractivates cursor (21).

It is also possible to rotate extremity (19) instead of extremity (20)and to simultaneously rotate the two extremities (19) and (20) inopposite directions.

According to one embodiment, the introducer may comprise an initial flatcentring valve further up from valve (15) deformable by twisting.

Advantageously, the flat centring valve is of the tricuspid orpunctiform type.

Adaptor (1) contains in its interior volume (3) at least one duct (4)allowing for the passage of surgical or medical instruments withelongated bodies.

According to one embodiment, adaptor (1) includes three ducts (4).

Advantageously, the ducts (4) comprise leakproof means at their proximalend (6) and/or distal end (5).

According to one embodiment, the ducts (4) include a haemostatic valve(22), preferably of the tricuspid type at proximal end (6) and/or ahaemostatic valve (7), preferably of the tricuspid type at distal end(5). Tricuspid refers to a valve in the shape of a flexible silicon orpolymer washer in the centre of which are three slots to enable theleakproof passage of instruments.

Advantageously, haemostatic valve (22) is held in place between asupport (8) and a washer (9). Advantageously, support (8) and washer (9)are pierced with a passage of the same diameter as the ducts (4) toenable the introduction of surgical instruments.

According to one embodiment, the ducts (4) comprise a removable stopper(not shown) at their proximal end (6) to block off unused ducts (4). Thestopper is placed above the haemostatic valve (22) and its washer (9).

According to one embodiment, the ducts (4) consist of one section (12)that is longitudinal compared to the elongated body (17) of the adaptor(1) and of a divergent proximal section (13). This configuration makesthe surgical instruments introduced into the adaptor easier to use.

The centres of the proximal openings (10) in ducts (4) are set outadvantageously according to a predetermined circle and, according to oneembodiment, a channel (11) lies in the centre of the circlepredetermined by the proximal openings (10) of the ducts (4).

Advantageously, said channel (11) has the same leakproof means as ducts(4). According to one embodiment, the channel (11) is rectilinear tomake it easier to handle the surgical instruments and, more especially,to allow for the passage of the guide wire.

According to one embodiment, adaptor (1) is characterised by a conicaldistal end (14) designed to guide and centre the insertion of adaptor(1) in the introducer (16). The distal end (14) is centred and supportedon the first flat valve located before the valve (15) deformable bytwisting previously opened by the operator. The distal end (14) ensuresthat there is no leakage between the adaptor (1) and the introducer (16)by continuously pressing on the first valve further up the device. Valve(15) deformable by twisting then presses on the elongated body (17) ofadaptor (1).

According to another embodiment, adaptor (1) is comprises a conicaldistal end (14) designed to facilitate the insertion of adaptor (1) inthe introducer (16) by opening valve (15), especially if valve (15) isdeformable by twisting. This is done if the valve deformable by twistingis in the closed position at the beginning of the procedure. The distalend (14) exerts pressure, gradually opening the valve which continues topress against the adaptor without any leakage.

According to one embodiment the ducts (4) have different diameters toreceive various types of surgical instruments.

REFERENCES

1. Adaptor

2. Outer surface

3. Inner volume

4. Duct

5. Distal end

6. Proximal end

7. Haemostatic valve

8. Valve holder

9. Washer

10. Proximal opening

11. Channel

12. Longitudinal section

13. Divergent proximal section

14. Distal extremity

15. Valve

16. Introducer

17. Elongated body

18. Skirt

19. Fixed extremity of the valve

20. Mobile extremity of the valve

21. Curser

22. Haemostatic valve

1-14. (canceled)
 15. An introducer (16) fitted with valve (15) for thehuman or animal body characterised by the fact that valve (15) isdeformable by twisting and able to receive adaptor (1) in its centre andable to press against the outer surface (2) of said adaptor (1); andthat the inner volume (3) of said adaptor (1) comprises at least oneduct (4) allowing the passage of surgical or medical instruments with anelongated body; and that the duct (4) comprises leakproof means.
 16. Anintroducer (16) with valve (15) according to claim 15 wherein the duct(4) of adaptor (1) comprises leakproof means at its proximal end (6).17. An introducer (16) with valve (15) according to claim 16 wherein theleakproof means at the proximal end of duct (4) comprise an haemostaticvalve (22).
 18. An introducer (16) with valve (15) according to claim 15characterised by the fact that the duct (4) comprises leakproof means atthe distal end (5).
 19. An introducer (16) with valve (15) according toclaim 18 characterised by the fact that the leakproof means the distalend (5) of duct (4) comprise an haemostatic valve (7).
 20. An introducer(16) with valve (15) according to claim 15 characterised by the factthat haemostatic valve (22) is held in place between a support (8) and awasher (9).
 21. An introducer (16) with valve (15) according to claim 15characterised by the fact that the centres of the proximal openings ofthe adaptor ducts are located in a predetermined circle.
 22. Anintroducer (16) with valve (15) according to claim 21 characterised bythe fact that a channel (11) is located in the centre of the circlepredetermined by proximal openings (10) of the ducts (4) and that saidchannel is rectilinear.
 23. An introducer (16) with valve (15) accordingto claim 15 characterised by the fact that the ducts (4) consist of asection that is roughly longitudinal (12) compared to the elongated body(17) of the adaptor (1) and a divergent proximal section (13).
 24. Anintroducer (16) with valve (15) according to claim 15 characterised bythe fact that the ducts (4) have different diameters.
 25. An introducer(16) with valve (15) according to claim 15 characterised by the factthat the adaptor has a conical distal extremity (14).
 26. An introducer(16) with valve (15) according to claim 15 characterised by the factthat the adaptor comprises means of attachment to the introducer (16).27. An introducer (16) with valve (15) according to claim 15characterised by the fact that the adaptor includes a cylindricalelongated body (17).
 28. An introducer (16) with valve (15) according toclaim 15 characterised by the fact that it has a flat centring valveable to cooperate with the distal end of the adaptor (1) to facilitateits insertion by centring it.